HealthyPhase 1NCT04556058
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects
A Phase 1 study testing Perindopril tert-Butylamine tablets （ Produced by Haisco） and Perindopril tert-Butylamine tablets（ACERTIL®） in people with Healthy, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
In order to evaluate the bioequivalence of the test preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Perindopril tert-Butylamine tablets （ Produced by Haisco） and Perindopril tert-Butylamine tablets（ACERTIL®）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2018to 15 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between the ages of 18 and 50 (including cut-off values), both male and female;
- Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) 19-26kg/m2 (including cut-off values);
- Sign the informed consent form voluntarily;
- Be able to maintain good communication with researchers and comply with various requirements of clinical trials.
Who cannot join
- People who is addicted to alcohol, tobacco,(drink 14 units of alcohol per week within the first month of enrollment: 1 unit = 285 ml of beer, or 25 ml of spirits, or 1 glass of wine; average daily smoking in the 3 months before screening ≥5) and/or those who cannot ban smoking and alcohol during the trial; or those who have a positive result alcohol breath trial;
- Use any prescription drugs (such as antihypertensive drugs) within 4 weeks before screening, or use any over-the-counter drugs (vitamins, Chinese herbal tonics) within 2 weeks before screening, or take foods that affect metabolism within 2 weeks before screening, such as grapefruit or a drink containing grapefruit (acetaminophen can be used, but it must be recorded in the concomitant medication of CRF); or the subject refused to stop using foods that affect CYP1A2 during the trial, such as coffee, tea, cola, chocolate, etc.
- Those who have used any drugs with a long half-life that may affect this study, or have participated in any drug clinical trials as subjects in the past 3 months;
- Blood donation or blood loss ≥ 400mL within 8 weeks before the first administration;
- People with a history of food or drug allergy, or allergies;
- Any clinically significant physical examination, vital signs, electrocardiogram or clinical laboratory measurement abnormalities during screening;
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- Suffer from blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental abnormality, metabolic abnormality or any other chronic or serious disease history or existing disease that may affect the results of the study Those with the aforementioned systemic diseases;
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TPPA) has a positive result;
- Those who have a history of drug abuse or drug dependence;
- People who have a history of fainting needles and blood, or who cannot tolerate venipuncture blood sampling and known serious bleeding tendency;
- Patients with resting systolic blood pressure ≤90 mmHg, ≥140mmHg, or diastolic blood pressure ≤60 mmHg, ≥90mmHg, or pulse (HR) ≤50bpm, ≥100bpm;
- Pregnant or lactating women, or female subjects whose pregnancy test results are positive; subjects (or their partners) have birth plans or sperm and egg donors during the entire trial period and within 3 months after the end of the study; trial Those who are unwilling to take one or more physical contraceptive measures during the period and within 3 months after the end of the study;
- Patients with congenital galactosemia, glucose and galactose malabsorption syndrome, or lack of lactase;
- Subjects who have poor compliance or who the researcher thinks are not suitable for inclusion in the group.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of the northern theater of the Chinese people's Liberation Army
Shenyang, Liaoning
About this study
Official title: Bioequivalence Study of Fasting Oral Perindopril Tert-butylamine Tablets in Healthy Subjects With a Single-dose, Randomized, Open, Two-cycle, Crossover Trial Design
In order to evaluate the bioequivalence of the test preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
Read the detailed description
This single-center, randomized, open-lable, single-dose, two-cycle,cross-over design bioequivalence test was conducted in subjects under fasting conditions. Subjects were fasted for at least 10 hours overnight in each cycle，but can't ban their from drinking water.The next morning according to test-reference (TR) or Reference-test (RT) sequential oral perindopril tert-butylamine tablets (4 mg, 240 mL warm water) . Each period was separated with a 14-day washout period in fasted trials. The blood concentrations of perindopril and perindoprilat in qualified subjects were tested. Safety assessment includes vital signs examination, physical examination, laboratory safety examination, coagulation examination, electrocardiogram and adverse event reports.
- Conditions
- Healthy
- Being tested
- Perindopril tert-Butylamine tablets （ Produced by Haisco）, Perindopril tert-Butylamine tablets（ACERTIL®）
- Keywords
- perindopril tert-butylamine, Bioequivalence study, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perindopril tert-Butylamine tablets （ Produced by Haisco）Drug
The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
Perindopril tert-Butylamine tablets（ACERTIL®）Drug
The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
| Study group | Role | What they receive |
|---|---|---|
| Perindopril tert-Butylamine tablets （ Produced by Haisco） | Experimental | The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg. Receives: Drug: Perindopril tert-Butylamine tablets （ Produced by Haisco） |
| Perindopril tert-Butylamine tablets（ACERTIL®） | Active comparator | The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg. Receives: Drug: Perindopril tert-Butylamine tablets（ACERTIL®） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration (Cmax) of Perindopril
Measured: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Area under the plasma concentration versus time curve （AUC0-∞、AUC0-t）of Perindopril
Measured: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Secondary outcomes (4)
Time to reach maximum plasma concentration(Tmax) of Perindopril and Perindoprilat
Measured: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Terminal elimination half-life（t1/2 ）of Perindopril and Perindoprilat
Measured: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Maximum drug concentration (Cmax) of Perindoprilat
Measured: fore administration (within 2 hours) and 10 minutes to 72 hours after administration
Area under the plasma concentration versus time curve （AUC0-∞、AUC0-t）of Perindoprilat
Measured: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start29 Nov 2018
- Primary completion8 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556058
- Sponsor's protocol ID
- SZYQ-BE-2018-004
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Fasting Oral Perindopril Tert-butylamine Tablets in Healthy Subjects With a Single-dose, Randomized, Open, Two-cycle, Crossover Trial Design
- ClinicalTrials.gov ID
- NCT04556058
- Acronym / sponsor ID
- SZYQ-BE-2018-004
- Conditions
- Healthy
- Keywords
- perindopril tert-butylamine, Bioequivalence study, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to evaluate the bioequivalence of the test preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
Detailed description
This single-center, randomized, open-lable, single-dose, two-cycle,cross-over design bioequivalence test was conducted in subjects under fasting conditions. Subjects were fasted for at least 10 hours overnight in each cycle，but can't ban their from drinking water.The next morning according to test-reference (TR) or Reference-test (RT) sequential oral perindopril tert-butylamine tablets (4 mg, 240 mL warm water) . Each period was separated with a 14-day washout period in fasted trials. The blood concentrations of perindopril and perindoprilat in qualified subjects were tested. Safety assessment includes vital signs examination, physical examination, laboratory safety examination, coagulation examination, electrocardiogram and adverse event reports.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perindopril tert-Butylamine tablets （ Produced by Haisco） | Experimental | Drug: Perindopril tert-Butylamine tablets （ Produced by Haisco）The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg. |
| Perindopril tert-Butylamine tablets（ACERTIL®） | Active comparator | Drug: Perindopril tert-Butylamine tablets（ACERTIL®）The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers between the ages of 18 and 50 (including cut-off values), both male and female;
- Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) 19-26kg/m2 (including cut-off values);
- Sign the informed consent form voluntarily;
- Be able to maintain good communication with researchers and comply with various requirements of clinical trials.
Key exclusion criteria (14 listed)
- People who is addicted to alcohol, tobacco,(drink 14 units of alcohol per week within the first month of enrollment: 1 unit = 285 ml of beer, or 25 ml of spirits, or 1 glass of wine; average daily smoking in the 3 months before screening ≥5) and/or those who cannot ban smoking and alcohol during the trial; or those who have a positive result alcohol breath trial;
- Use any prescription drugs (such as antihypertensive drugs) within 4 weeks before screening, or use any over-the-counter drugs (vitamins, Chinese herbal tonics) within 2 weeks before screening, or take foods that affect metabolism within 2 weeks before screening, such as grapefruit or a drink containing grapefruit (acetaminophen can be used, but it must be recorded in the concomitant medication of CRF); or the subject refused to stop using foods that affect CYP1A2 during the trial, such as coffee, tea, cola, chocolate, etc.
- Those who have used any drugs with a long half-life that may affect this study, or have participated in any drug clinical trials as subjects in the past 3 months;
- Blood donation or blood loss ≥ 400mL within 8 weeks before the first administration;
- People with a history of food or drug allergy, or allergies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perindopril tert-Butylamine tablets （ Produced by Haisco）The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg. | Drug | Perindopril tert-Butylamine tablets （ Produced by Haisco） |
| Perindopril tert-Butylamine tablets（ACERTIL®）The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg. | Drug | Perindopril tert-Butylamine tablets（ACERTIL®） |
Primary outcome
Maximum drug concentration (Cmax) of Perindopril
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Area under the plasma concentration versus time curve （AUC0-∞、AUC0-t）of Perindopril
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
4 secondary outcomes
Time to reach maximum plasma concentration(Tmax) of Perindopril and Perindoprilat
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Terminal elimination half-life（t1/2 ）of Perindopril and Perindoprilat
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Maximum drug concentration (Cmax) of Perindoprilat
Time frame: fore administration (within 2 hours) and 10 minutes to 72 hours after administration
Area under the plasma concentration versus time curve （AUC0-∞、AUC0-t）of Perindoprilat
Time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Perindopril tert-Butylamine tablets （ Produced by Haisco） and Perindopril tert-Butylamine tablets（ACERTIL®） in people with Healthy, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum drug concentration (Cmax) of Perindopril (time frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.